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flipper44

03/16/22 1:22 PM

#451991 RE: exwannabe #451978

1. You think it’s (TLD delay) about NWBO delaying indefinitely to avoid announcing trial failure.

2. Biosect thinks the delay is about lack of guideline finalization.

3. NWBO seems to portray the TLD delay is about Journal publication time issues, and nothing else.

4. I believe the TLD delay is due to Parties awaiting green light for Flaskwork certification for commercial manufacturing.

5. Others believe that the TLD delay is due to NWBO awaiting on at least one regulator granting marketing approval.

What’s clear is the Covid delay used in the current 10k was really about pre-data lock delay. No one can figure out why so much time has passed without an update as to what’s going on with TLD/publication timeline and eventual Flaskwork’s certification application timeline estimate.

Hspooner

03/16/22 2:08 PM

#452009 RE: exwannabe #451978

Examples that are related and relevant to NWBO?? Or just more BS.
“ Other bios continue to complete trials, announce TLD, publish papers and even get approvals in record times. The FDA is still doing well on meeting or exceeding PDUFA dates. ”